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Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) (VADT)

This study has been completed.
National Eye Institute (NEI)
SmithKline Beecham
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: March 21, 2002
Last updated: February 28, 2017
Last verified: February 2017
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Insulin
Drug: Glimepiride
Drug: Rosiglitazone
Drug: Metformin

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Arm 1/Standard Glycemic Control Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
Arm 2/Intensive Glycemic Control Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
Total Total of all reporting groups

Baseline Measures
   Arm 1/Standard Glycemic Control   Arm 2/Intensive Glycemic Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 899   892   1791 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      606  67.4%      612  68.6%      1218  68.0% 
>=65 years      293  32.6%      280  31.4%      573  32.0% 
[Units: Years]
Mean (Standard Deviation)
 60.3  (9.0)   60.5  (9.0)   60.4  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      26   2.9%      26   2.9%      52   2.9% 
Male      873  97.1%      866  97.1%      1739  97.1% 
Region of Enrollment 
[Units: Participants]
United States   899   892   1791 

  Outcome Measures
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1.  Primary:   Primary Major Macrovascular Events   [ Time Frame: Post baseline time to the first major macrovascular event up to 82 months ]

2.  Secondary:   Secondary Endpoint   [ Time Frame: Post baseline time to first event up to 82 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our study had several limitations. Since we were studying veterans, the patients were predominantly men, and extrapolation of our findings to women must be done with caution.Changes in therapeutic agents have occurred since the design of our protocol

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